Unsafe Medical Devices & Drugs

The German drug manufacturer Boehringer Ingelheim has announced that it will pay a settlement of $650 million in response to hundreds of thousands of cases against its blood-thinning drug, Pradaxa. The company defends that the settlement is to avoid a lengthy legal battle against claims that ‘lacked merit’ from the outset, or in their words, “to avoid the distraction and uncertainty of lengthy litigation and focus on our mission of improving patients’ lives.” In contrast, victims defend that their lives were far from improved. Plaintiffs contend that the company did not provide adequate warning about the severe bleeding and …

Brian Nettles, Esq. The FDA has warned that there is reason for concern over the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) and uterine fibroids (myomectomy), because it may spread cancerous tissue, such as uterine sarcomas. Laparoscopic power morcellation is a technique that uses a device to divide uterine fibroids into smaller pieces for surgical removal. This poses risk of spreading if the uterine fibroids are a type of unsuspected cancerous tissue called uterine sarcoma. While most women develop noncancerous uterine fibroid growths at some point in their lifetime, approximately 1 in 350 women undergoing …

Elise Sanguinetti, Esq. Johnny Fortune lost his wife due to complications in knee surgery on September 11, 2010. Mrs. Fortune had suffered a cardiac arrest. Months later, however, Mr. Fortune discovered that Granuflo, a treatment Mrs. Fortune was prescribed three times a week since early 1998, was more likely the reason for the tragedy. It is known that Mrs. Fortune had three hemiodialysis treatments with Granuflo while at University Hospital for her knee surgery. Granuflo was recalled in March 2012 by the FDA for potentially causing “serious adverse health consequences, including death.” Granuflo, also known as Naturalyte, is used for …

Tad Thomas, Esq. The case accuses DePuy of continuing sale of the device despite being aware of its exponential failure rate and serious potential for injury to consumers. DePuy only chose to phase out device after the FDA made safety inquiries, and did not share FDA reports with international clients. The device was finally recalled after the FDA received more than a thousand negative reports about its performance. About 93,000 people received the ASR, a third of those implants were performed in the U.S. While artificial hips usually last about 15 years before they need to be replaced, DePuy’s ASR …

Richard Schulte, Esq. at www.legaldayton.com This week the FDA made game changing moves dealing with American health and drug manufacturer liability. Their hope, is that fair game will be established between brand name and generic manufacturers—and that means equal liability. FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011). The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their …